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CLEARFIL MAJESTY ES Flow is indicated for the following restorative applications:

• [1] Direct restorations for all cavity classes, cervical lesions (e.g. root surface caries, v-shape defects), tooth wear, and tooth erosion
• [2] Cavity base / liner
• [3] Correction of tooth position and tooth shape (e.g. diastema closure, tooth malformation)
• [4] Intraoral repair of fractured restorations
• [5] Cementation of ceramic and composite inlays, onlays and veneers with less than 2mm thickness

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The provided text is a 510(k) clearance letter from the FDA for a dental restorative material called CLEARFIL MAJESTY ES Flow. It details the device's indications for use and regulatory classification. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested information based on the given input text. The information typically found in a 510(k) clearance letter focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance study results and acceptance criteria. Such detailed study information would usually be found in the 510(k) submission itself or in published studies related to the device.

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CLEARFIL MAJESTY ES Flow is indicated for the following restorative applications:

[1] Direct restorations for all cavity classes, cervical lesions (e.g. root surface caries, v-shape defects), tooth wear, and tooth erosion
[2] Cavity base / liner
[3] Correction of tooth position and tooth shape (e.g. diastema closure, tooth malformation)
[4] Intraoral repair of fractured restorations

The subject device, CLEARFIL MAJESTY ES Flow is a light-cure, flowable, radiopaque restorative material which provides accurate color matching, high polishability and excellent physical properties, making it ideal for both anterior and posterior restorations.

It is classified into tooth shade resin material (21 CFR section 872.3690, Product code:EBF) according to 21 CFR8872 since it is composed of materials such as methacrylate monomers.

The provided text describes a 510(k) summary for a dental restorative material, "CLEARFIL MAJESTY ES Flow." It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study for device acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable or not provided in this document, as the device is a dental material, not an AI or algorithm.

However, I can extract the information relevant to the material's performance and acceptance based on the provided text, particularly the comparison to the predicate device and compliance with an ISO standard.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not applicable / Not provided. The study referenced is a comparison to a predicate device and compliance with an ISO standard for material properties, not a clinical study on an AI/algorithm where a "test set" in the context of data points would be relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not provided. This section refers to a dental restorative material, not an AI/algorithm device requiring expert adjudication of ground truth.

4. Adjudication method for the test set

• Not applicable / Not provided. As above, no expert adjudication process is described for this type of material evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a dental restorative material, not an AI-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical dental material, not an algorithm.

7. The type of ground truth used

• For effectiveness: Compliance with an international standard (ISO 4049:2009).
• For biocompatibility: Evaluation against international standards (ISO 10993 series and ISO 7405) and historical safety data from predicate devices.

8. The sample size for the training set

• Not applicable / Not provided. No "training set" is relevant for this type of material evaluation.

9. How the ground truth for the training set was established

• Not applicable / Not provided. No "training set" or corresponding ground truth establishment is relevant for this type of material evaluation.

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EsFlow is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.

EsFlow is light-cured flowable composite resin which makes it ideal for small cavities in anterior and posterior teeth. It has the characteristics of good flowability, high compressive strength, and radiopaque. It has 17 shades: A1, A2, A3, A3.5, B2, B3, I, UO, LA1,LA2,LA3, LA3.5, LB2, LB3,LUO, White, Yellow.

The provided text is a 510(k) summary for a dental resin material, EsFlow, and does not contain information about acceptance criteria for a device, nor does it describe a study proving a device meets such criteria in terms of performance metrics like sensitivity, specificity, or any clinical outcomes.

Instead, the document focuses on demonstrating that EsFlow is substantially equivalent to a predicate device (ESTELITE FLOW QUICK, K051808) based on:

• Intended use
• Material and chemical composition
• Design and use concept
• Mechanical properties (compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage, thermal expansion coefficient)
• Biocompatibility and other safety tests in compliance with US regulations and ISO 4049.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample sizes, ground truth, expert opinions, or MRMC studies, as these types of studies are not detailed in this 510(k) summary for a dental material. The document is about demonstrating substantial equivalence for regulatory clearance, not about clinical performance data in the way you've outlined.

Ask a specific question about this device